About this trial
Left paratracheal pressure (LPP) has been proposed as an alternative to cricoid pressure to reduce the risk of regurgitation during induction of general anesthesia. Previous studies suggest that LPP can effectively compress the esophagus without significantly reducing left carotid blood flow. However, its effect on cerebral oxygenation has not yet been evaluated.
The aim of this prospective randomized crossover study is to assess whether application of LPP affects regional cerebral oxygen saturation measured by near-infrared spectroscopy (NIRS) during general anesthesia.
Seventy adult patients undergoing elective surgery under general anesthesia with tracheal intubation will be included. After induction of anesthesia and stabilization, cerebral oxygen saturation will be continuously measured under three conditions: no cervical pressure, left paratracheal pressure at 30 N, and cricoid pressure at 30 N. The order of the two pressure maneuvers will be randomized.
The primary objective is to determine the change in left regional cerebral oxygen saturation during LPP compared with baseline without cervical pressure.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years
Scheduled for elective surgery requiring general anesthesia with orotracheal intubation
American Society of Anesthesiologists (ASA) physical status I to III
Ability to understand the study information
Disqualifiers
Refusal to participate
Known or suspected pregnancy
Emergency surgery
Inability to provide informed consent
Trial design
Crossover
Treatments tested in this trial
Left Paratracheal Pressure
Procedure/SurgeryA standardized cricoid pressure of 30 N will be applied for 45 seconds using a calibrated force-measuring device. Regional cerebral oxygen saturation, hemodynamic variables, and respiratory variables will be continuously recorded during the intervention.
Cricoid Pressure
Procedure/SurgeryA standardized cricoid pressure of 30 N will be applied for 45 seconds using a calibrated force-measuring device. Regional cerebral oxygen saturation, hemodynamic variables, and respiratory variables will be continuously recorded during the intervention.
Treatment groups
Trial outcomes
Primary outcomes
Maximum Change in Left Regional Cerebral Oxygen Saturation During Left Paratracheal Pressure
Maximum absolute change in left regional cerebral oxygen saturation (rSO2), expressed in percentage points, during application of left paratracheal pressure at 30 N compared with the baseline value obtained without cervical pressure.
Secondary outcomes
Maximum Change in Right Regional Cerebral Oxygen Saturation
Maximum absolute change in right regional cerebral oxygen saturation (rSO2), expressed in percentage points, during application of each cervical pressure maneuver compared with the baseline value obtained without cervical pressure.
Difference in Change in Left Regional Cerebral Oxygen Saturation Between LPP and Cricoid Pressure
Within-participant difference in the maximum absolute change in left regional cerebral oxygen saturation (rSO2), expressed in percentage points, between left paratracheal pressure at 30 N and cricoid pressure at 30 N.
Difference in Regional Cerebral Oxygen Saturation Between the Left and Right Hemispheres
Difference in regional cerebral oxygen saturation (rSO2), expressed in percentage points, between the left and right cerebral hemispheres during baseline, left paratracheal pressure, and cricoid pressure.
Change in Mean Arterial Pressure
Change in mean arterial pressure (MAP), measured in mmHg, during left paratracheal pressure and cricoid pressure compared with baseline.
Sponsors and contacts
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